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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21
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The information on this page is current as of Dec 22, 2023.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 3]
[CITE: 21CFR172.623]



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER B - FOOD FOR HUMAN CONSUMPTION (CONTINUED)

PART 172 -- FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION

Subpart G - Gums, Chewing Gum Bases and Related Substances

Sec. 172.623 Carrageenan with polysorbate 80.

Carrageenan otherwise meeting the definition and specifications of § 172.620 (a) and (b) and salts of carrageenan otherwise meeting the definition of § 172.626(a) may be safely produced with the use of polysorbate 80 meeting the specifications and requirements of § 172.840 (a) and (b) in accordance with the following prescribed conditions:

(a) The polysorbate 80 is used only to facilitate separation of sheeted carrageenan and salts of carrageenan from drying rolls.

(b) The carrageenan and salts of carrageenan contain not more than 5 percent by weight of polysorbate 80, and the final food containing the additives contains polysorbate 80 in an amount not to exceed 500 parts per million.

(c) The carrageenan and salts of carrageenan so produced are used only in producing foods in gel form and only for the purposes defined in §§ 172.620(c) and 172.626(b), respectively.

(d) The carrageenan and salts of carrageenan so produced are not used in foods for which standards of identity exist unless the standards provide for the use of carrageenan, or salts of carrageenan, combined with polysorbate 80.

(e) The carrageenan and salts of carrageenan produced in accordance with this section, and foods containing the same, in addition to the other requirements of the Act, are labeled to show the presence of polysorbate 80, and the label or labeling of the carrageenan and salts of carrageenan so produced bear adequate directions for use.

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